Drug delivery device

ABSTRACT

A drug delivery device for injecting medicament, the device including a main body having a surface for contacting a patient, an actuation button ( 110, 420, 436 ) movably disposed relative to the main body, and a reservoir disposed within the main body for containing a medicament. The device also includes a needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, wherein said lumen is fluidly connectable with the reservoir. The device further includes a removable needle cover ( 114, 400 ) for selectively covering the distal end of the needle and selectively preventing movement of the actuation button relative to the main body that initiates activation of the device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 USC §119(e) from U.S.Provisional Patent Application Ser. No. 61/819,443 filed on May 3, 2013,the disclosure of which is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to a drug delivery device for parenteraladministration of a medicament.

BACKGROUND OF THE INVENTION

Drug delivery devices in the form of infusers are known in the prior artfor administering medicament to a patient. Infusers are intended formounting onto a patient's skin for self-administration of a medicament.Activation of the infuser not only provides for injection of a needleinto a patient's skin, but also to cause auto-drive of a plunger todrive medicament into the patient via the injected needle. Typicalinfuser constructions have the needle fixed to the reservoir. Forexample, with reference to U.S. Pat. No. 5,858,001 to Tsals et al., aninfuser is disclosed that is activated through swivel displacement of areservoir-containing body. A needle that is also caused to penetrate theskin of a patient with the swivel displacement of the body is attachedto the Tsals et al. device. The needle is fixed to the body to movetherewith. Other types of infusers are known, including those which usestandard needle-mounted syringe barrels. With many infusers, the abilityto control the insertion of the needle independent of the administrationof medicament is limited.

PCT Publication WO 2011/146166, which is hereby incorporated byreference in its entirety, discloses an infuser in which activation ofan actuator causes a spring to move a stopper in a reservoir from afirst position toward a second position, and also causes a needle driverto displace a patient needle from a first state toward a second state.The needle moves relative to the reservoir, and separately from thestopper.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Accordingly, it is an aspect of the present invention to provide amedical device with improved user operation and safety.

The foregoing and/or other aspects of the present invention are achievedby providing a drug delivery device for injecting medicament, the deviceincluding a main body having a surface for contacting a patient, anactuation button movably disposed relative to the main body, and areservoir disposed within the main body for containing a medicament. Thedevice also includes a needle having a distal end for insertion into apatient, and a lumen extending proximally from the distal end, whereinsaid lumen is fluidly connectable with the reservoir. The device furtherincludes a removable needle cover for selectively covering the distalend of the needle and selectively preventing movement of the actuationbutton relative to the main body that initiates activation of thedevice.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will be more readily appreciated from the following detaileddescription, taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a top perspective view of infusion medical device inaccordance with an embodiment of the present invention;

FIG. 2 is a bottom perspective view of the device of FIG. 1;

FIG. 3 is a perspective view illustrating the relationship between abutton and a needle cover in a pre-activated stage, in accordance withan embodiment of the present invention;

FIG. 4 is a top perspective view of the device of FIG. 1 in apre-activation stage with a top cover removed;

FIG. 5 is a partial perspective view illustrating the interaction ofcomponents of a power pack of the device of FIG. 1 in the pre-activatedstage;

FIG. 6 is an exploded perspective view of the components illustrated inFIG. 5;

FIG. 7 is a perspective view of a barrel plunger of the device of FIG.1;

FIG. 8 is a perspective view of an outer telescoping member of thedevice of FIG. 1;

FIG. 9 is a perspective view of a needle actuation plunger of the deviceof FIG. 1;

FIG. 10 is a partial perspective view of the device of FIG. 1;

FIG. 11 is a bottom perspective view of a lever of the device of FIG. 1;

FIG. 12 is a perspective view of a needle arm of the device of FIG. 1;

FIG. 13 is a perspective view of a needle activation slider of thedevice of FIG. 1;

FIGS. 14 and 15 are respective top and bottom perspective views of aswitch arm of the device of FIG. 1;

FIG. 16 is a perspective view of a rocker of the device of FIG. 1;

FIG. 17 is a perspective view of the rocker of FIG. 16 and a valve plateof the device of FIG. 1;

FIG. 18 is a perspective view of one side of a valve cover of the deviceof FIG. 1;

FIG. 19 is a perspective view of another side of the valve cover of FIG.18;

FIG. 20 is a perspective view of the device of FIG. 1 in thepre-activated stage, with several elements removed for clarity;

FIG. 21 is a top perspective view of the device of FIG. 1 in a firstactivation stage with the top cover removed;

FIG. 22 is a cross-sectional view of the device of FIG. 1 in the firstactivation stage with the top cover removed;

FIG. 23 is a cross-sectional view of the device of FIG. 1 in a secondactivation stage with the top cover removed;

FIG. 24 is a top perspective view of the device of FIG. 1 in the secondactivation stage;

FIG. 25 is a cross sectional view of a port, a patient needle, and aneedle cover portion in accordance with an embodiment of the presentinvention;

FIG. 26 is a top perspective view of the port and needle cover portionof FIG. 25 and a button lock portion in accordance with an embodiment ofthe present invention;

FIGS. 27 and 28 are top perspective views of a button retractionmechanism in accordance with an embodiment or the present invention;

FIGS. 29-31 are respective top, top, and bottom perspective views of abutton retraction mechanism in accordance with another embodiment or thepresent invention;

FIG. 32 is a top perspective view of a locking mechanism for selectivelypreventing activation of a drug delivery device in accordance with anembodiment of the present invention;

FIG. 33 is a top perspective view of a lift lever of the mechanism ofFIG. 32;

FIGS. 34 and 35 are respective top and bottom perspective views of anembodiment of a stage-indicating mechanism in accordance with anembodiment of the present invention;

FIG. 36 is a top perspective view of a needle activation slider inaccordance with another embodiment of the present invention;

FIG. 37 is a partial top perspective view of a top cover in accordancewith another embodiment of the present invention;

FIG. 38 is a top perspective view of a switch arm in accordance withanother embodiment of the present invention;

FIG. 39 is a top perspective view of the switch arm of FIG. 38 and aneedle activation slider in accordance with another embodiment of thepresent invention;

FIG. 40 is a partial top perspective view of a bottom cover inaccordance with an embodiment of the present invention;

FIG. 41 is a partial top perspective view of the switch arm of FIG. 38and the cover of FIG. 40;

FIGS. 42 and 43 are respective top and bottom perspective views of aswitch arm in accordance with another embodiment of the presentinvention;

FIG. 44 is a top perspective view of the switch arm of FIG. 42 and theneedle activation slider of FIG. 36;

FIG. 45 is a top perspective view of a another needle arm in accordancewith an embodiment of the present invention;

FIG. 46 is a top perspective view of a another needle arm in accordancewith an embodiment of the present invention;

FIG. 47 is a top perspective view of a port in accordance with anembodiment of the present invention;

FIG. 48 is a rear perspective view of power module elements of thedevice of FIG. 1;

FIG. 49 is a rear perspective view of power module elements inaccordance with another embodiment of the present invention;

FIG. 50 is a bottom perspective view of a shutter latching mechanism inaccordance with another embodiment of the present invention;

FIG. 51 is a bottom perspective view of a shutter latching mechanism inaccordance with another embodiment of the present invention;

FIG. 52 is a rear perspective, cross-sectional view of a frame inaccordance with an embodiment of the present invention;

FIGS. 53 and 54 are top perspective views of needle actuation plungersin accordance with embodiments of the present invention;

FIGS. 55 and 56 are top perspective views of shutters in accordance withembodiments of the present invention;

FIG. 57 is a top perspective, exploded view of a two-part barrel plungerin accordance with an embodiment of the present invention;

FIG. 58 is a top perspective view of a plunger link in accordance withanother embodiment of the present invention;

FIG. 59 is a top perspective rear view of a medical device in accordancewith an embodiment of the present invention in a pre-activation stageand with a top cover removed;

FIG. 60 is a top perspective front view of the device of FIG. 59 withseveral elements removed;

FIG. 61 is a top perspective view of a rocker in accordance with anotherembodiment of the present invention;

FIG. 62 is an exploded, top perspective view of a portion of a valveassembly in accordance with an embodiment of the present invention;

FIG. 63 is a cross-sectional, perspective plan view of a valve assemblyin accordance with an embodiment of the present invention;

FIG. 64 is a partial perspective view of the valve assembly of FIG. 63;

FIG. 65 is a side cross-sectional view of the valve assembly of FIG. 63;

FIG. 66 is a bottom perspective view of a valve assembly in accordancewith another embodiment of the present invention;

FIG. 67 is a partial, cross-sectional, plan view of the valve assemblyof FIG. 66;

FIG. 68 is a perspective view of a tub for containing syringes;

FIG. 69 is a perspective view of a fluid path subassembly in accordancewith an embodiment of the present invention;

FIG. 70 is an exploded perspective view of the fluid path subassembly ofFIG. 69;

FIG. 71 is a perspective view illustrating installation of the fluidpath subassembly into the device of FIG. 1;

FIG. 72 is a perspective view of a fluid path subassembly in accordancewith another embodiment of the present invention;

FIG. 73 is a partial cross-sectional view of the fluid path subassemblyof FIG. 72 with a valve cover removed for clarity;

FIG. 74 is an enlarged, partial cross-sectional view of the fluid pathsubassembly of FIG. 72;

FIGS. 75 and 76 are respective perspective views of a septum holder anda connector of the fluid path subassembly of FIG. 72; and

FIG. 77 is a flow chart illustrating a process of assembly of the deviceof FIG. 1.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings, whereinlike reference numerals refer to like elements throughout. Theembodiments described herein exemplify, but do not limit, the presentinvention by referring to the drawings. As will be understood by oneskilled in the art, terms such as up, down, bottom, and top arerelative, and are employed to aid illustration, but are not limiting.

FIG. 1 is a top perspective view of an infusion device or infuser 100for infusing a medicament into a patient. Although a user other than amedicament recipient (for example, a health care professional) can usethe device 100, for brevity, the term “user” will be employedhereinafter to refer to a patient or other user. The device 100 has atop cover 102 and a bottom cover 104 that, together, form a main body106. The device 100 also includes a reservoir or syringe barrel 108, abutton 110, and a status viewport 112. Through the status view port 112,as will be subsequently described in greater detail, a user can view theprogress of the infusion of the medicament. For example, the device 100can function in three stages: a pre-activated stage (ready foractivation), a first activation stage, and an end-of-dose or secondactivation stage. According to one embodiment, an indicator is visiblethrough the viewport 112 to indicate each of these three stages. As anexample, three colors can be used to represent the three stages. Asother examples, three numbers, three symbols, three letters, or threewords or phrases can be visible through the viewport 112 to representthe three stages. According to one embodiment, as shown in FIG. 1, aportion 113 of the viewport 112 is slanted. This reflects light into theviewport 112 and aids the user in viewing the status of the device 100.

FIG. 2 is a bottom perspective view of the device 100, which includes aremovable needle cover 114. Preferably, the needle cover 114 ismanufactured in a two-shot molding process. As shown in FIG. 2, the tab116 of the needle cover 114 preferably folds substantially parallel toand against the bottom of the device 200, on which there is an adhesive118 for attaching the device to a patient's skin. According to oneembodiment, the adhesive 118 is an adhesive pad secured on one side tothe bottom cover 104, and having a patient adhesive on the opposingside. A removable adhesive liner preferably protects the patientadhesive, and is removed prior to securing the device to the patient'sskin.

According to one embodiment, as shown in FIG. 2, the bottom cover 104also includes one or more access slots 119, through which an assemblercan, for example, access the button 110 and/or the needle cover 114during assembly of the device 100.

FIG. 3 is a perspective view illustrating the relationship between thebutton 110 and the needle cover 114 in the pre-activated stage. As shownin FIG. 3, the needle cover 114 includes a safety extension 120 thatextends through the bottom cover 104 and engages an engagement hole 122of the button 110. This engagement prevents the button 110 from movingand activating the device 100 prior to removal of the needle cover 114.

According to one embodiment, the safety extension 120 and the needlecover 114 are integrally formed as a unitary construction. According toanother embodiment, the safety extension 120 is originally formed as aseparate element, and subsequently joined to the needle cover 114, forexample, by snapping the safety extension into a recess in the needlecover 114, or using an adhesive.

To remove the needle cover 114, the user unfolds the tab 116 about ahinge 117 (for example, a living hinge 117) to extend substantiallyperpendicular to the bottom cover 104, and then pulls the needle cover114 out of the device 100, thereby uncovering a hollow patient needle124 and permitting movement of the button 110. Preferably, the userremoves the release liner and then removes the needle shield 114,thereby freeing the button 110 for movement, as subsequently describedin greater detail. Optionally, the user removes the release liner fromthe adhesive 118 subsequent to removing the needle cover 114, or theyare removed in a combined fashion.

According to one embodiment, the release liner and the needle cover 114are connected, and the release liner is retained on the needle cover 114after removal from the infusion device. Such an embodiment allows theuser to easily recycle or dispose of the connected release liner andneedle cover 114. Examples of ways to connect a release liner and aneedle cover can be found in the commonly-owned internationalapplication published as WO 2011/075101, the disclosure of which isincorporated herein in its entirety.

FIG. 4 is a top perspective view of the device 100 in the pre-activatedstage with the top cover 102 removed. The device 100 includes a valvecover 126, a rocker 128, a needle arm 130, a lever 132 that rotatesabout a pivot 134, a shutter 136, and a frame 138 that houses theshutter 136 and guides its movement. For reference purposes, the shutter136 is disposed at a first end of the main body 106 and the rocker 128is disposed at a second end of the main body 106.

FIGS. 5-9 illustrate several components of a power pack 1380 of thedevice 100 in the pre-activated stage. In particular, FIG. 5 is apartial perspective view illustrating the interaction of severalcomponents with the shutter 136 in the pre-activated stage. For clarity,the shutter 136 is illustrated as being transparent in FIG. 5, althoughone skilled in the art will appreciate that the shutter's opacity canvary without departing from the present invention's scope. FIG. 6 is anexploded perspective view of the components illustrated in FIG. 5. FIG.7 illustrates a barrel plunger 152, FIG. 8 illustrates anouter-telescoping member 146, and FIG. 9 illustrates a needle actuationplunger 166. Optionally, the power pack 1380 also includes the frame138.

As shown most clearly in FIG. 6, the shutter 136 includes asubstantially U-shaped arm cutout 140 and a through arm slot 142 toslidingly accommodate sliding arms 144 of the outer telescoping member146. The shutter 136 also has a barrel plunger cutout 148 with a notch149 at a top thereof, and a barrel plunger engaging surface 150 toengage the barrel plunger 152, as subsequently described in greaterdetail. The shutter 136 additionally has a horizontally oriented latchslot 154 for selectively engaging the shutter latch 156. Further, theshutter 136 includes a biasing arm 158 and a needle actuation cutout 160defining first and second engaging surfaces 162 and 164 for engagementwith the needle actuation plunger 166, as will also be subsequentlydescribed in greater detail. The biasing arm 158 biases the shutter 136toward the barrel side of the device 100.

As shown in FIG. 5, in the pre-activated stage, the barrel plunger 152is disposed within the outer telescoping member 146 and engages thebarrel plunger engaging surface 150 of the shutter 136 at a barrelshutter-engaging structure 168 (best shown in FIG. 6). According to oneembodiment, the barrel shutter-engaging structure 168 is defined by apair of cutouts with a bridge structure 169 disposed therebetween thatengages the notch 149 of the shutter 136 in the pre-activated stage. Thebarrel plunger 152 also includes a stopper seat 170 on which a stopper172 is disposed (see, for example, FIG. 21), and a pair of cantileveredplunger arms 174. A pair of plunger hooks 176 is respectively disposedat the free ends of the cantilevered plunger arms 174, as shown in FIG.7.

At a first end thereof, a barrel spring 178 engages the frame 138. Thebarrel spring 178 is disposed in an annular cavity 177 of the barrelplunger 152 (see FIG. 7), and at its second end, the barrel spring 178engages the interior of the barrel plunger 152. Accordingly, the barrelspring 178 biases the barrel plunger 152 toward the second end of themain body 106.

As shown in FIGS. 5, 6 and 8, the outer telescoping member 146 has apair of sliding arms 144 extending from the first end thereof, and alsohas a pair of teeth 180 extending from the second end that engage withcorresponding engagement slots 182 in the barrel plunger 152. Inaddition, a cantilevered arm 181 and a foot 183 form a stabilizingfeature that is slightly depressed or deflected radially inward duringassembly to prevent the outer telescope member 146 and elementsconnected thereto from rocking. In the pre-activated stage, the slidingarms 144 slidably engage the arm slot 142 and arm cutout 140 of theshutter 136. As subsequently described in greater detail, and as bestshown in FIG. 8, the outer telescoping member 146 additionally has astopped groove 182 in which the barrel plunger's plunger hooks 176 areslidably disposed. In other words, the groove 182 does not run theentire axial length of the interior of the outer telescoping member 146.

As shown in FIGS. 5, 6, and 9, the needle actuation plunger 166 has asecond engaging structure 186 at a first end thereof, for engaging thesecond engaging surface 164 of the shutter 136 during the firstactivation stage. According to one embodiment, the second engagingstructure 186 is a foot extending from the needle actuation plunger 166.At the opposing, second end of the needle actuation plunger 166, thereis a protrusion 188 and a flange 190 that has a spring-engaging surface192 and a slider-engaging surface 194. As subsequently described ingreater detail (and illustrated in FIG. 20), the protrusion 188 and theslider-engaging surface 194 engage and position a needle activationslider 196.

The needle actuation plunger 166 also has a cylindrical portion 198 forsupporting a needle actuation spring 200, and a first engaging structure202 for engaging the first engaging surface 162 of the shutter 136during the pre-activation stage. As shown in FIGS. 5, 6, and 9, thefirst engaging structure 202 in one embodiment is a transverse groove inthe needle actuation plunger 166. According to one embodiment, at leastone side of the transverse groove is inclined or sloped. The needleactuation spring 200 engages the frame 138 at a first end of the spring,and engages the spring-engaging surface 192 of the flange 190 at asecond end of the spring.

According to one embodiment, the shutter latch 156 is rotatably disposedon the bottom cover 104, and has a hook 184 for selectively engaging thelatch slot 154 in the shutter 136. As noted previously, during thepre-activated stage, the hook 184 of the shutter latch 156 is engagedwith the latch slot 154. In addition, as shown in FIG. 10, a blockingarm 204 of the lever 132 engages the shutter latch 156 and prevents itfrom rotating, thereby maintaining the hook 184 in engagement with thelatch slot 154, and thus preventing the shutter 136 from moving.According to one embodiment, the shutter latch is biased away from theshutter 136, for example, by a spring (not shown).

FIG. 11 is a bottom perspective view of the lever 132, which includesthe previously described laterally-extending pivots 134 and blocking arm204, and also includes a loading element 218 that biases the needle arm130 during operation of the device 100. The lever pivots 134 movablyengage a corresponding pair of lever pivot mounts 135 (see FIG. 4) inthe bottom cover 102.

As shown in FIG. 12, the needle arm 130 includes a pair of detents orwings 210 extending laterally from a first end, and a pair of pivots 212extending laterally from a second end. The pivots 212 movably engage acorresponding pair of arm pivot mounts 213 (see FIG. 4) in the bottomcover 102. A port 238 is mounted to the first end of the needle arm 130,and the patient needle 124 extends from the needle hub or port 238.According to one embodiment, the patient needle 124 is hollow with asharpened distal end, is made of surgical stainless steel, has a gaugeof 29, and has an overall length of 11.5 mm for a subcutaneouspenetration of about 4-6 mm. One skilled in the art will appreciate thatthe material, gauge, end-treatment, and length of the patient needle 124can vary without departing from the scope of the present invention. Forexample, the length and gauge of the patient needle can be optimized forsubcutaneous infusion, or for intradermal infusion. A connecting tube228 (see, for example, FIG. 27) connects a valve plate 232 and the port238 to form part of the medicament flow path.

Turning to FIG. 13, the needle actuator or slider 196 has a pair ofloading cliffs 214, a pair of depth stops 216, a pair ofneedle-retracting ramps 222, a pair of pivot ramps 224, and a pair ofpivot ledges 220. As subsequently described in greater detail, duringoperation of the device 100, the slider 196 moves toward the second endof the device 100, and thereby controls the movement of several of thecomponents of the device 100. For example, the wings 210 of the flexibleneedle arm 130 are disposed on the loading cliffs 214 during thepre-activated stage. During the first activation stage, as subsequentlydescribed in greater detail, due to the displacement of the slider 196,the wings 210 slide off the loading cliffs 214 and contact the depthstops 216, which limit the insertion depth of the patient needle 124.Also, the loading element 218 of the lever 132 (shown in FIG. 11) ispositioned beneath the pivot ledges 220, thereby preventing the lever132 and the button 110 from lifting during the first activation stage.Further, during the second activation stage, the needle 124 is retractedinto the device 100 because the wings 210 ride along theneedle-retracting ramps 222, and the button 110 is lifted because theloading element 218 is lifted by the pivot ramps 224 as the slider 196travels farther forward. The angle of the needle-retracting ramps can bevaried to effect the desired timing or speed of the needle withdrawalwithout departing from the present invention's scope.

The slider 196 also includes a stage-indicating structure 226 with areas227, 229, and 231 for indicating the pre-activated stage, firstactivation stage, and second activation stage, respectively, though thestatus viewport 112. As noted previously, each of these areas can have adifferent color, number, letter, word, phrase, combination of theseindicators, or some other indicator to represent the different stages ofoperation of the device 100. According to one embodiment, as shown inFIG. 13, the face of the stage-indicating structure 226 that houses theareas 227, 229, and 231 is disposed at an angle to match the viewport112, and to thereby be more readily visible through the viewport 112.

The second end of the slider 196 contacts a switch arm 206, which isshown in FIGS. 14 and 15. The switch arm 206 has a pair of leg postsextending from a bottom thereof, and has a rocker post 208 extendingfrom a top thereof to engage a switch collar 246 of the rocker 128,which is illustrated in FIG. 16. A central portion 248 of the rocker 128pivots about a post on the bottom cover 104, and a plate-engagingstructure 250 is disposed on the opposite end of the rocker 128 from theswitch collar 246. One skilled in the art will appreciate thatdimensions of the rocker 128, for example, the distance between theswitch collar 246 and the central portion 248, or the distance betweenthe central portion 248 and the plate-engaging structure 250 can bemodified without departing from the present invention's scope to providea desired mechanical advantage to the rocker. For example, the ratio ofthe force input to the rocker relative to the force output of the rocker128 is preferably from about 0.8:1.0 to 1.0:1.0. As the ratio increases,the force required from the needle actuation spring 200 to open thevalve is reduced.

As shown in FIG. 17, the plate-engaging structure 250 engages the valveplate 232. According to one embodiment, the valve plate 232 is movablyconnected with the plate-engaging structure 250. Preferably, however,the plate-engaging structure 250 simply contacts the valve plate 232.The valve plate 232 includes a plurality of guiding wings 252 thatmaintain the orientation of the valve plate relative to the valve cover126 during movement of the valve plate 232. The valve plate 232 alsoincludes a valve port 254 fluidly connected to a hollow valve needle234. The connecting tube 228 or tubing 228 connects the valve port 254to the port 238 disposed on the end of the needle arm 130. For clarity,the connecting tube 228 is omitted from the majority of the drawings,but is shown, for example, in FIG. 27.

As shown in FIG. 18, the valve cover 126 has a plurality of slots 256corresponding to the guiding wings 252 of the valve plate 232. The slots256 guide the guiding wings 252 during displacement of the valve plate232 relative to the valve cover 126. The opposing side of the valvecover 126 includes a pair of cantilevered arms 258 with hooks 260disposed at the free end thereof, as shown in FIG. 19, for securing thesyringe barrel 108 with the valve cover 126.

FIG. 20 is a perspective view of the device 100 in the pre-activatedstage, with several elements removed for illustrative purposes. Theprotrusion 188 and the slider-engaging surface 194 of the needleactuation plunger 166 engage the slider 196 at the first end thereof. Atthe second end, the slider 196 engages the movable switch arm 206, thepost 208 of which engages the rocker 128. The detents or wings 210 ofthe needle arm 130 are disposed on the loading cliffs 214 of the slider196.

After removing the adhesive liner, the user secures the device 100 tothe user's skin. To activate the device 100 and enter the firstactivation stage (shown in FIGS. 21 and 22), the user slides the button110 forward, and at the end of the forward motion, pushes button 110down. According to one embodiment, to the user, this feels like a singlemotion. For example, it can feel like sliding the button 110 on a rampwith a flat (horizontal) portion at the top of the ramp. The downwardpush of the button 110 rotates the lever 132 about the pivots 134. Thislever rotation moves the loading element 218 down to deflect a middleportion of the flexible needle arm 130, thereby loading the needle arm130. In other words, the deflection of the middle portion of the needlearm 130 biases the first end of the needle arm 130 (and thereby, thepatient needle 124) to rotate down. Because the wings 210 are stillresting on the loading cliffs 214, however, the patient needle 124 ismaintained within the device 100.

Once the lever 132 rotates, the blocking arm 204 no longer preventsmovement of the shutter latch 156. And once the shutter latch 156 ispermitted to move, because the needle actuation plunger 166 is biased bythe spring 178 toward the second end of the main body 106, the needleactuation plunger 166 moves and the sloped side of the first engagingstructure 202 of the needle actuation plunger 166 displaces the shutter136 upward. This frees the needle actuation plunger 166 and the barrelplunger 152 to move longitudinally forward toward the second end of themain body 106 under the force of their respective springs 178 and 200.The needle actuation plunger 166 moves forward until the second engagingstructure 186 contacts the second engaging surface 164 of the shutter136. The spring 200 continues to move the plunger 166 forward. Althoughthe timing of events can be varied without departing from the presentinvention's scope, it is preferable that the loading element 218 biasesthe patient needle prior to the initial forward movement of the needleactuation plunger 166.

The forward displacement of the needle actuation plunger 166 until thesecond engaging structure 186 contacts the second engagement surface 164longitudinally displaces the slider 196 forward toward the second end ofthe main body 106. Briefly, this displacement of the slider 196 causesthe patient needle 124 to extend outside of the main body 106 (into theskin of the patient) and causes a valve to open, thereby permitting themedicament to flow from the syringe barrel 108, through the tubing 228,and through the hollow patient needle 124.

In more detail, as the slider 196 moves forward under the force of thespring 200, via the plunger 166, the end of the loading cliff 214reaches the wings 210, and because of the bias induced by the loadingelement 218, the patient needle quickly rotates down to extend outsideof the main body 106 and into skin of the patient, as shown in FIG. 22.The wings 210 contact the depth stop 216 to limit movement of thepatient needle 124. Put another way, the insertion depth of the patientneedle 124 is determined by the length of the patient needle 124 and theheight of the depth stop 216.

In addition, as the slider 196 moves forward under the force of thespring 200, the pivot ledge 220 of the slider 196 moves over the loadingelement 218 of the lever 132, thereby preventing the lever 132 and thebutton 110 from moving upward, and maintaining the loading on the needlearm 130. The forward movement of the slider 196 also displaces theswitch arm 206 forward. Because of the engagement of the post 208 withthe rocker 128, as shown in FIG. 21, the forward motion of the switcharm 206 rotates the rocker 128 about a rocker pivot 230, therebydisplacing the valve plate 232 toward the first end of the bottom cover204.

According to one embodiment, the valve includes a valve septum 236 (see,for example, FIG. 31) disposed at the forward end of the syringe 108,and the valve needle 234 fixedly connected to the valve plate 232.According to one embodiment, the valve needle 234 is a whitacre needlehaving a conical tip and a side port (see FIG. 31). The shape of thewhitacre needle 234 prevents coring of the valve septum 236. As thevalve needle 234 is displaced by the motion of the rocker 128, the sideport passes through the valve septum and communicates with themedicament in the syringe 108. The valve needle 234 communicates withthe tubing 228, which is connected to the patient needle 124 at the port238 on the needle arm 130. It will be understood by one skilled in theart that other valve mechanisms or valve assemblies can be used withoutdeparting from the present invention's scope. For example, although notshown, the valve needle can be fixed relative to the main body 106 andthe valve septum can move to complete the fluid connection between thesyringe 108 and the patient needle 124. Additionally, as subsequentlydescribed in greater detail, valve mechanisms or assemblies without aneedle and septum can be employed.

Furthermore, as the slider 196 moves forward, the portion of thestage-indicating structure 226 visible through the status viewport 112changes from the area 227 to the area 229, indicating the change fromthe pre-activation stage to the first activation stage. Also, as theslider 196 pushes the switch arm 206 forward, after a predeterminedtravel distance, the leg posts 244 of the switch arm 206 enter a floorrecess 242 (best shown in FIG. 20) in the bottom cover 204 and theswitch arm 206 drops down. As subsequently described in greater detail,this permits the second, or front end of the slider 196 to travel over aportion of the switch arm 206 during the second activation stage. Thisfunctionality permits a greater travel for the slider 196 within theconfines of the main body 106. In other words, it allows the device 100to be more compact.

Also during the first actuation stage, as previously noted, the barrelplunger 152 moves longitudinally forward toward the second end of themain body 106 under the force of the barrel spring 178, thereby movingthe stopper 172 forward. This pressurizes the medicament in the syringe108.

Preferably, although the release of the barrel plunger 152 and theneedle activation plunger 166 from the shutter 136 is substantiallysimultaneous, their release and subsequent forward motions areindependent. By changing the travel distance of the respective plungersor other elements, the timing of events can be determined. For example,according to one embodiment, it is preferable to pressurize themedicament prior to the opening of the valve.

As the barrel plunger 152 moves forward and pushes the medicamentthrough the tubing 228 and patient needle 124 during the firstactivation stage, referring back to FIGS. 5 and 6, the barrel plungerhooks 176 engage the stopped ends of the stopped grooves 182. Continuedforward motion of the barrel plunger 152 pulls the outer telescopingmember 146 forward. Once the sliding arms 144 slide out of engagementwith the shutter 136, the biasing arm 158 of the shutter 136 displacesthe shutter 136 toward the barrel side of the bottom cover 104, therebyautomatically initiating the second activation stage or end-of-dosestage. The length of the sliding arms can be varied to vary the timingof the end-of-dose stage initiation.

As the shutter 136 displaces toward the barrel side of the bottom cover104, the second engaging surface 164 of the shutter 136 slides out ofengagement with the second engagement structure or foot 186 of theneedle actuation plunger 166. Because of the continued forward bias bythe needle actuation spring 200, the needle actuation plunger 166displaces further forward and drives the slider 196 further forward andover the rear portion of the switch arm 206. Briefly, this secondaryforward movement of the slider 196 retracts the patient needle 124,rotates the lever 132 upward and raises the button 110, and makes theend-of-dose indicator 231 visible through the status viewport 212.

In greater detail, as the slider 196 moves farther forward during thesecond activation stage, the needle-retracting ramps 222 of the slider196 engage the wings 210, thereby retracting the patient needle 124 backinto the main body 106. Similarly, with the additional forward motion ofthe slider 196, the pivot ramps 224 of the slider 196 engage the loadingelement 218 of the lever 132 and rotate the lever 132 back up about thepivot 134, thereby releasing the loading of the needle arm 130 andraising the button 110, as shown in FIG. 23.

As shown in FIG. 24, with the secondary movement of the slider 196, theportion of the stage-indicating structure 226 visible through the statusviewport 112 changes to the area 231, indicating the change from thefirst activation stage to the second activation stage (or end-of-dosestage). According to one embodiment, continued forward motion of theslider 196 is prevented by interference with the main body 106.

Once the end-of dose stage has been attained, the user can remove thedevice 100 from his or her skin and safely dispose of the device 100.

FIGS. 25 and 26 illustrate another embodiment of a needle cover 400.FIG. 25 is a cross sectional view of a port 300, the patient needle 124,and a needle cover portion 302 that includes a tab 304. One end of thetubing 228 connects to the valve plate 232 and the other end connects tothe port 300. According to one embodiment, the needle cover 302 ismanufactured in a two-shot molding process, with a first molding shotportion 306 and a second molding shot portion 308. As shown in FIG. 26,in combination with the needle cover portion 302, a button lockingportion 402 forms the needle cover 400. The button lock portion 402includes a safety extension 404 that engages the button or actuationbutton in a similar manner as the previously-described safety extension120. As subsequently described in greater detail, this embodimentpermits the needle cover portion 302 (along with the port, the patientneedle, and other components of the fluid pathway) to be sterilizedprior to assembly with the button lock portion 402. The button lockportion 402 and the needle cover portion 302 can be joined in severaldifferent ways, or a combination of ways, including snap-fit features, afriction fit, and an adhesive.

The medical device can include a feature for retracting the actuationbutton to an initial position if the button is displaced subsequent tothe removal of the needle cover, but not sufficiently displaced toactivate the device. For example, FIGS. 27 and 28 illustrate a mechanismfor retracting the actuation button 406. A fixed pin 410 is fixedlydisposed in the lever or lift lever 408 and a movable pin 412 is fixedlyconnected to the underside of the button 406, but permitted to move in aslot 414 in the lift lever 408. According to one embodiment, the pins410 and 412 are held in place by friction, but other methods of securingthe pins 410 and 412, such as an adhesive, can be employed withoutdeparting from the present invention's scope. A spring 416 connects thetwo pins 410 and 412. If the button 406 is displaced by a distance thatis insufficient to activate the device and subsequently released, thespring 416 retracts the movable pin 412 (and thus, the button 406) toits initial position. For example, if the user does not apply sufficientforce to the button 406 to activate the device and then releases it, thebutton 406 will return to its initial position. This feature can helpprevent accidental actuation and aid device assembly.

FIGS. 29-31 illustrate another embodiment to achieve the same goals.Rather than pins, both the lift lever 418 and the button 420 includehooks. More specifically, as shown in FIGS. 29 and 30, the lever 418 hasa lever hook 422 disposed on a top thereof, and as shown in FIG. 31, thebutton 420 has a button hook 424 disposed on its bottom side. A spring426 connects the two hooks 422 and 424. The button hook 424 travels in aslot 428 in the lever 420 when the button is displaced. Similar to thepreviously-described embodiment, subsequent to the removal of the needlecover, if the button 420 is displaced by a distance insufficient toactivate the device and then released, the spring 426 retracts thebutton hook 424 (and thus, the button 420) to its initial position shownin FIG. 29. In addition, the slot 428 and the positioning of the leverhook 422 to the rear of the lever 418 provides additional clearance forthe needle arm and port when the needle is retracted.

FIG. 32 is a perspective view of a locking mechanism for selectivelypreventing activation of a drug delivery device in accordance with anembodiment of the present invention. The mechanism includes a needlecover 430 with a safety extension 432, a lift lever 434, and anactuation button 436. The button 436 includes a pair of flexible,cantilevered snap arms 438 separated laterally by a distancesubstantially equal to a lateral dimension of the proximal end of thesafety extension 432. A pair of angled locking protrusions 440 isrespectively disposed at the free ends of the snap arms 438.

As shown in FIGS. 32 and 33, the lift lever 434 includes a track 442that the snap arms 438 ride against. According to one embodiment, oneach side, the track 442 has a pair of detents 444 and 446. In aninitial position and prior to removal of the needle cover 430, the snaparms 438 are held in place or locked against the track 442 by the needlecover 430. In other words, the safety extension 432 prevents the snaparms 438 from displacing toward each other and disengaging from thedetents 444. Once the needle cover 430 is removed, the user is able toslide the button 436 forward toward the second end of the device. Duringthis movement of the button 436, because of the forward angled faces ofthe detents 444 and the forward angled faces of the locking protrusions440, the free ends of the snap arms 438 laterally deform or deflecttoward each other, thereby permitting the locking protrusions todisengage from the detents 440 and engage the detents 446. Once thisoccurs, according to one embodiment, because of the interaction of therear angled faces of the detents 446 and the rear angled faces of thelocking protrusions 440, the user cannot return the button to itsinitial position.

Thus, according to one embodiment, the actuation button 436 includes atleast one cantilevered snap arm 438, and prior to needle cover removal,the snap arm 438 engages a detent 444 in the device and the safetyextension 432 contacts the snap arm 439 and prevents the snap arm 438from disengaging from the detent 444.

When the button 436 is in the initial position and the needle cover 430is removed, unless the user applies sufficient force to deflect the snaparms 438 inward and engage the locking protrusions 440 with the detents446, the interaction between the forward angled faces of the detents 444and the forward angled faces of the locking protrusions 440, combinedwith the flexibility of the snap arms 438, causes the button 436 returnsto its initial position with the locking protrusions engaged with thedetents 444.

The angles of the forward faces of the locking protrusions 440 and theforward faces of the detent 444 can be modified to adjust a forceprofile required from the user to activate the medical device. Forexample, the obtuse angle between the of the forward face of the lockingprotrusion 440 and the straight portion of the snap arms 438 can beincreased (and the corresponding angle of the forward face of the detent444 can be modified) to lower the amount of force required by a user toovercome the interaction with the detent 444 and activate the device.Preferably, the force required to activate the device is between about4-10 N (0.9-2.2 lb_(F)).

In contrast to the stage-indicating structure 226 shown in FIG. 13,another embodiment of a stage-indicating mechanism is illustrated inFIGS. 34 and 35. The mechanism includes an indicator 448 and anindicator guide 450. The indicator guide 450 is fixedly connected to thetop cover 452 and includes a cantilevered arm 454 and a guide slot 456vertically supporting and guiding the indicator 448. The free end of thecantilevered arm 454 includes an indicator face 458 and an angledsliding surface 460. Prior to activation, the indicator face 458 isvisible through the status viewport of the top cover 452 to indicatethat the device has not yet been activated. This embodiment providesmore room for assembling fluid path components in the device.

The top surface of the indicator includes an area indicating the firstactivation stage 464 and an area indicating the second activation stage466. The end of indicator has an angled surface 468 that issubstantially complimentary to the angled sliding surface 460 of thecantilevered arm 454. When the device is assembled, the indicator 448 isadjacent to and contacts the needle activation slider or slider 462, butis not connected to the slider 462. Instead, subsequent to activation,as the slider displaces, the slider moves the indicator 448.

More specifically, as previously described, during the first activationstage, the slider 462 displaces forward by a first distance (permittingthe needle insertion into the user). In this embodiment, the firstforward displacement of the slider also displaces the indicator 448forward. The forward displacement of the indicator 448 causes the angledsurface 468 to ride over the angled sliding surface 460, downwardlydeflecting the free end of the cantilevered arm 454, and displaying thearea indicating the first activation stage 464 through the statusviewport. During the second activation stage, the slider 462 displacesforward by a second distance, and displaces the indicator 448 forward todisplay the area indicating the second activation stage 466 through thestatus viewport.

FIG. 36 illustrates another embodiment of the needle activation slideror slider 470. Similar to the slider 196, in this embodiment, the slider470 includes a stage-indicating structure 472 fixedly connected thereto.But rather than being disposed at the forward end, in this embodiment,the stage-indicating structure 472 is disposed on the side of the slider470. The stage-indicating structure 472 includes an area indicating thepre-activated stage 474, and area indicating the first activation stage476, and an area indicating the second activation stage 478. As shown inFIG. 37, the various stage-indicating areas (474, 476, and 478) arevisible through the status viewport 480 of the top cover 482.

FIG. 38 illustrates another embodiment of a switch arm or flip arm 484.Prior to the device's activation, the rear portion of the switch arm 484resides in a recess of the needle activation slider 462, as shown inFIG. 39. In addition, as shown in FIGS. 40 and 41, the bottom cover 486includes a switch arm track 488 for guiding movement of the switch arm484. FIG. 41 illustrates the switch arm prior to activation of thedevice. Front protrusions 490 rest on an upper track portion 492 and therear portion of the switch arm 484 rests on the initial track portion494.

Subsequent to activation, during the first activation stage, the slider462 displaces forward by a first distance, displacing the switch arm 484forward (to rotate the rocker) until the rear portion of the switch arm484 falls off the initial track portion onto a lower track portion 496.By lowering the rear portion of the switch arm 484 in this manner, theslider 462 can pass over the rear portion of the switch arm 484 withoutfurther displacing the switch arm 484 during the second activationstage. This configuration allows the slider 462 to travel a greaterinternal total distance

FIGS. 42 and 43 are respective top and bottom perspective views of aswitch arm or flip arm 498 in accordance with another embodiment of thepresent invention. The switch arm 498 includes a pair of rearcantilevered arms 500, each having a snap protrusion 502 on its freeend. The switch arm 498 also includes a guide rail 504 disposed on abottom thereof that rides in a guide track in the bottom cover (notshown) to guide movement of the switch arm 498.

Prior to activation, the snap protrusions 502 rest against the forwardend of the slider 470. Subsequent to activation, during the firstactivation stage, the slider 470 displaces forward by a first distance,displacing the switch arm 498 forward (to rotate the rocker) to itsfinal forward position. According to one embodiment, at the beginning ofthe second activation stage, the slider 470 displaces further forward,but because the switch arm 498 does not displace further forward, theforward end of the slider 470 rides against the angled surfaces of thesnap protrusions 502, deflecting the two cantilevered arms 500 towardeach other. Further forward motion of the slider 470 bypasses the snapprotrusions 502, as shown in FIG. 44, thereby permitting the slider 470to travel further forward still. According to another embodiment, theforward end of the slider 470 bypasses the snap protrusions 502 at theend of its travel during the first activation stage. Additionally, asshown in FIG. 44 and subsequently described in greater detail, theslider 470 includes a rear protrusion 471 for registration with theneedle actuation plunger.

FIGS. 45 and 46 illustrate alternative embodiments of the needle arm. Asshown in FIG. 45, the needle arm 506 includes two pair of substantiallyvertical guide posts 508 for guiding installation and preventing lateraldisplacement of the tubing of the fluid pathway. In contrast, the needlearm 510 of FIG. 46 includes two pairs of snap guides 512 to which thetubing is secured during installation. Additionally, according to oneembodiment, the pivots 514 and the corresponding pivot yokes 516 (see,for example, FIG. 40).

FIG. 47 is a top perspective view of a port 518 in accordance with anembodiment of the present invention. In contrast to thepreviously-described port 300 (see, for example, FIG. 25) which makes avertical connection with the tubing, the port 518 makes a substantiallyhorizontal connection with the tubing. This provides for less bending ofthe tubing during installation and additional clearance for the tubingonce the needle is withdrawn.

FIG. 48 is a rear perspective view of a power module of the device 100,illustrating the relative positioning of the frame 138, the shutter 136,and the needle actuation plunger 166 prior to activation of the device100. In contrast, FIG. 49 illustrates another embodiment of the frame520 that substantially encloses the shutter except for its top, andsupports the bottom of the needle actuation plunger 522 during itstravel.

FIG. 50 is a bottom perspective view of a shutter latching mechanism 523in accordance with an embodiment of the present invention. The shutterlatching mechanism of this embodiment includes the lift lever 418, alatch beam 424, the shutter latch 526, and the shutter 528 illustratedprior to activation The lift lever 418 (also shown in FIG. 30) includesa lifting arm 530 that engages the latch beam 424, which keeps theshutter latch 526 engaged with the shutter 528. The latch beam 524 is anL-shaped element having a long portion 532 and a short portion 534.According to one embodiment, the short portion 534 is secured in apocket of the frame 520. Preferably, the latch beam 424 is made of sheetmetal or spring metal, and is strong but flexible.

In operation, when the device is activated, the front portion of thelift lever 418 rotates down (due to the user force on the button),thereby rotating the rear portion of the lift lever 418 up and liftingor deflecting the long portion 532 of the latch beam 524 so that it nolonger contacts and supports the shutter latch 526. Subsequently, as inpreviously-described embodiments, the shutter latch 526 is freed fromthe shutter 528 and the needle actuation plunger 522 lifts the shutter528.

FIG. 51 is a bottom perspective view of a shutter latching mechanism535, and FIG. 52 is a rear perspective cross-sectional view of a frameor power module frame 541. The shutter latching mechanism of thisembodiment includes the lift lever 434, a swing arm 536, the shutterlatch 538, and the shutter 540 illustrated prior to activation inaccordance with an embodiment of the present invention. The lift lever434 (also shown in FIG. 33) includes a lifting arm 542 that engages theswing arm 536, which selectively keeps the shutter latch 538 engagedwith the shutter 540.

The swing arm 536 is rotatably connected to the frame 541 at a stud 543(see FIG. 52), and is preferably made of plastic. Prior to activation,the free end of the swing arm 536 is disposed beneath a frame protrusion545. In operation, when the device is activated, the front portion ofthe lift lever 434 rotates down (due to the user force on the button),thereby raising the lifting arm 542 and rotating the swing arm 536 sothat the free end is disposed above the frame protrusion 545 and theswing arm 536 no longer contacts and supports the shutter latch 538.Subsequently, as in previously-described embodiments, the shutter latch538 is freed from the shutter 540 and the needle actuation plunger 548(see FIG. 54) lifts the shutter 540.

In contrast to the shutter latching mechanism 523 shown in FIG. 50, inthe embodiment shown in FIGS. 51 and 52, the swing arm 536 and theshutter latch 538 are located on the rear side of the shutter 540 andframe 541. This arrangement combined with the longer lifting arm 542increases the lifting arm's effective travel. In addition, being able tomake the swing arm out of plastic and its arrangement in the mechanismhelps prevent creep prior to activation of the device.

FIGS. 53 and 54 are top perspective views of needle actuation plungersin accordance with embodiments of the present invention. In comparisonto the previously-described needle actuation plunger 166 (shown in FIG.9), the needle actuation plunger 522 (also shown in FIG. 49) has a lowerfirst engaging structure 544, and the second engaging structure 546 isangled. The needle actuation plunger 548 in FIG. 54 has a similarconfiguration with a lower first engaging structure 550 and an angledsecond engaging structure 552. Additionally, the needle actuationplunger 548 has a cavity 553 with a front opening that receives theslider's rear protrusion 471 (shown in FIG. 44). By linking the plunger548 and the slider 470, the interaction between the cavity 553 and therear protrusion 471 provides registration and guidance for the plunger548 during its travel. The needle actuation plungers 522 and 548 can bemade of plastic or metal, for example, aluminum.

The lower first engaging structures 544 and 550 do not lift the shutteras high, and the angled second engaging structures 546 and 552 providethe side force to the shutter once the sliding arms 144 of the outertelescope member 146 displace and no longer contact the shutter, therebyeliminating the need for the biasing arm 158 of the shutter 136. Thus,in contrast to the previously-described shutter 136, the shutter 528(shown in FIGS. 50 and 55) and the shutter 540 (shown in FIGS. 51 and56) lack such a biasing arm.

FIG. 57 illustrates an embodiment of a two-part barrel plunger 554,which includes a plunger portion 556 and a plunger link 558. Accordingto one embodiment, both the plunger portion 556 and the plunger link 558have a cruciform shape. The plunger portion cruciform engages the barrelstopper and the plunger link cruciform engages the interior of theplunger portion cruciform, securing the two elements and preventingtheir relative rotation. Shapes other than a cruciform can be usedwithout departing from the present invention's scope.

FIG. 58 illustrates a plunger link 560 in accordance with anotherembodiment of the present invention. The plunger link 560 includes alift ramp 562 for lifting the shutter in concert with the needleactuation plunger's first engaging structure. Having both elements liftthe shutter substantially simultaneously and to substantially the sameheight reduces the likelihood that the shutter will rack during lifting.

FIG. 59 is a top perspective view of a medical device 600 incorporatingselected ones of the previously-described features. For example, thedevice 600 includes the frame 541, the swing arm 536, the needle cover430, the lift lever 434, the actuation button 436, the needle activationslider 470, the needle arm 506, and the switch arm 498. The device 600also includes a valve assembly 602, which includes the rocker 604, avalve release cap 606, and a septum fitting 608 disposed about the valverelease cap 606, as shown in FIG. 59. The septum fitting 608 has a sideport 618 connected to tubing 610 that fluidly connects to the patientneedle.

As shown in FIGS. 60 and 61, at the rocker's first end, the collar 611that interfaces with the post of switch arm 498 is open, and at itssecond or valve end, the rocker 604 has a pair of arms 612. The ends ofthe rocker arms 612 include angled faces 614. As subsequently describedin greater detail, upon activation of the device 600, the rocker armssplay apart the septum fitting's cantilevered base arms 616.

FIG. 62 is an exploded view illustrating additional components of thevalve assembly 602, and FIG. 63 is a cross-sectional perspective planview of the valve assembly 602. The septum fitting 608 includes teeth620 at its first end that correspond with teeth 622 disposed at a firstend of a one-piece plug valve 624, to prevent relative rotation betweenthe septum fitting 608 and the plug valve 624. The plug valve 624 has acentral lumen that fluidly communicates with the tip of the syringebarrel 108, and also has a side port 626 connected with the centrallumen and aligned with the septum fitting's side port 618. The valverelease cap 606 includes an end block 634 for securing the valve releasecap 606 in a pre-activated position, and a guide block 636 that ridesagainst a registration surface of the septum fitting 608 to preventrelative rotation between the septum fitting 608 and the valve releasecap 606.

Prior to activation, as shown in FIG. 63, retaining protrusions at thefree end of the septum fitting's base arms 616 retain an end block 634of the valve release cap 606. An inner spring 630 is disposed within acavity 632 of the valve release cap 606 and biases a valve impactor 628toward the syringe barrel 108. Under the force of the inner spring 630,the valve impactor contacts and elastically deforms the end of the plugvalve, thereby causing an internal valve protrusion 638 to seal thesyringe barrel tip 626 and prevent medicament in the syringe barrel 108from flowing through the side ports 626 and 618.

Upon activation, as illustrated in FIG. 64, the as the rocker arms 612rotate toward the syringe barrel 108, they contact and displace thesplaying protrusions 617, splaying the free ends of the septum fitting'scantilevered base arms 616, and releasing the end block 634 from theretaining protrusions 619. Subsequently, as shown in FIG. 65, the rockerarms 612 bypass the splaying protrusions 617, and the spring 630 forcesthe valve release cap away from the syringe barrel 108. Because thespring 630 is substantially no longer biasing the valve impactor 628,the plug valve 624 returns to its un-deformed shape, displacing theinternal valve protrusion 638 out of sealing engagement with the tip ofthe syringe barrel 108 and permitting medicament in the syringe barrel108 to flow through the side ports 626 and 618.

FIG. 66 is a bottom perspective view of a valve assembly 640 and FIG. 67is a partial, cross-sectional, plan view of the valve assembly 640.FIGS. 66 and 67 illustrate a state prior to device activation. The valveassembly includes a lid 642 hingedly connected to a lid retainer 644, avalve case 646 connected with the tip of the syringe barrel 108, a valvebody 648 disposed within the valve case and having a central lumen 650fluidly communicating with the interior of the syringe barrel 108, anelastomeric valve member 652, and a cover 654 securing the valve member652 to the valve body 648.

The lid retainer 644 includes a cantilevered retainer arm 656 with acatch 658 to selectively retain the lid 642. The lid 642 includes a lidprotrusion 660 for selectively compressing the valve member 652 to sealthe valve body's central lumen 650. The valve member 652 includes one ormore sealing protrusions 662 (for example, a protrusion and a ring) thatseal the central lumen 650 when the valve member 652 is compressed bythe lid 642. The valve member 652 also includes a side port 664 forcommunicating with the patient needle via the tubing.

Upon device activation, an angled rocker arm (not shown) wedges up theretainer arm 656 freeing the catch 658 from the lid 642. Once the lid642 is freed, the valve body 648 returns to its un-deformed shape, androtates the lid away from the syringe barrel 108 while unsealing thecentral lumen 650, thereby permitting the medicament to flow from thesyringe barrel 108, through the central lumen 650, and through theinterior of the valve body 648 to the side port 664.

Except for needles and septa, unless otherwise specified the preferredmaterials for the components of the medical devices described herein aresuitable plastics, such as ABS. Other suitable plastics can also beemployed.

FIG. 68 illustrates a tub 262 for containing and processing (forexample, filling) syringes, such as 10 mL BD Hypak™ syringes. Oneskilled in the art will appreciate that any size syringe can be used andthe tub can be sized and configured accordingly. The tub can be a fourinch tub and can accommodate 42 barrels (Hypak™ syringes) per tub. Assubsequently described in greater detail, the manufacturing process forthe device 100 utilizes components that allow for the use of such tubsand standard syringe processing equipment.

FIG. 69 is a perspective view of a fluid path subassembly 264 inaccordance with an embodiment of the present invention, and FIG. 70 isan exploded perspective view of the fluid path subassembly 264. Thefluid path subassembly 264 includes the syringe barrel 108, the stopper172 (not shown in FIGS. 69 and 70), the valve cover 126, an adapter 266for connecting the syringe barrel 108 with the valve cover 126, thehollow valve needle 234, the valve plate 232, and a locking element orlock 268 to selectively prevent the valve plate 232 from moving withrespect to the valve cover 126. According to one embodiment, the valveseptum 236 is disposed within the adapter 266. The fluid pathsubassembly 264 also includes the connecting tube 228, the port orneedle hub 238, the hollow patient needle 124, the needle cover 114, anda sacrificial retainer 270 for holding the components of the fluid pathsubassembly 264 prior to installation in the bottom cover 104.

In other words, the fluid path subassembly 264 includes all of theelements of the device that contact the medicament fluid plus theretainer 270 and the locking element 268. Additionally, the elements ofthe fluid path subassembly 264 minus the barrel 108 and the stopper 172form a flow pathway subassembly 272, as subsequently described ingreater detail. Although fluid path subassembly 264 in this embodimentis envisioned to be used in device 100, such a fluid path subassemblycan also be utilized in other types of devices, such as autoinjectors,medication pens, and virtually any pre-filled device that requiressterility maintenance in the fluid path.

Preferably, the retainer 270 is re-usable. According to one embodiment,the retainer also includes a balancing feature or balancing weight 274(see FIG. 69) for balancing the flow pathway subassembly 272 (as well asthe fluid path subassembly 264) about its central longitudinal axis. Inother words, preferably, the center of gravity of the flow pathwaysubassembly 272 is disposed on the central longitudinal axis, so thatthe subassembly 272 is rotationally balanced about the centrallongitudinal axis.

The balancing weight 274 can be connectable to the main body of theretainer 270, or alternatively, can be integrally formed with the mainbody of the retainer 270. According to one embodiment, the balancingweight 274 is adjustable relative to the main body of the retainer 270.For example, the balancing weight 274 can be affixed to differentlocations on the main body of the retainer 270. Alternatively, if thebalancing weight 274 is integrally formed with the retainer's main body,for example, as a weight at the end of a cantilevered arm, the arm canbe deformed or deflected to position the balancing weight 274. Assubsequently discussed in greater detail, during inspection, the fluidpath subassembly 264 is rotated at high speeds about its centrallongitudinal axis (for example, axis A in FIG. 69), so it is preferablethat it be rotationally balanced about that axis).

As shown most clearly in FIG. 69, the retainer 270 has a path forlooping and storing the connecting tube 228. This provides forspace-efficient storage of the connecting tube 228, as well asprotection for the tube 228. The retainer 270 also provides forconvenient handling of the fluid path subassembly 264.

Once assembled, the fluid path subassemblies 264, which aresubstantially the same size as a 10 mL BD Hypack™ barrel, can be loadedinto a four-inch tub that can accommodate 42 fluid path subassemblies264. Because of the additional components in a fluid path subassembly264, the syringe barrel 108 is smaller than a 10 mL Hypak™ barrel.According to one embodiment, the syringe barrel 108 can be filled withabout 2-5 mL of medicament. Because of the size similarity of the fluidpath subassembly 264 with respect to a Hypak™ barrel, equipmentstandardized for filling and moving Hypak™ barrels can be utilized tofill and move fluid path subassemblies 264.

Once the syringe barrel 108 has been filled with medicament and thestopper 172 has been inserted in the barrel 108, the medicament fluidpath is self-contained, and therefore, sterile packaging or storage isnot required. Instead, the fluid path subassemblies 264 can be storedand subsequently installed into the device 100 in a standard clean room.

To install the fluid path subassembly 264 into the bottom cover 104, theinstaller unwinds the tubing 228 from the retainer 270, which is thendiscarded, re-used, or recycled. The installer secures the needle hub orport 238 at the end of the needle arm 130 and inserts the barrel 108 andvalve cover 126 into the bottom cover 104, as shown in FIG. 71.Subsequently, the installer removes the locking element 268, which isthen also discarded, re-used, or recycled.

FIGS. 25 and 72-76 illustrate another embodiment of a fluid pathsubassembly 278. The retainer 280 includes first and second retainingmembers 282 and 284. In this embodiment, the syringe barrel 108, thestopper 172, the valve cover 126, valve plate 232, the valve needle 234,the patient needle 124, and the tubing 228 are substantially similar tothose previously described. Accordingly, the description of theseelements is omitted for brevity. In addition, the valve cover 126 isomitted from FIG. 73 for clarity.

As shown in FIGS. 73 and 74, the first and second retaining members 282and 284 have inward-protruding walls to engage the valve plate 232 andfix its position within the valve cover 126. Thus, without the use of aseparate locking element (such as the previously-described lockingelement 268), the retainer 280 prevents movement of the valve plate 232relative to the valve cover 126. Optionally, the retainer 280 has abalancing weight (not shown) similar to the previously-describedbalancing weight 274, to ensure that the center of gravity of the flowpath assembly 278 lies on the central longitudinal axis thereof.

A two-piece adapter 288 includes a septum holder 290 and a connector 292for connecting to a neck of the tip of the syringe barrel 108. Theseptum holder 290 secures a valve septum 294 that is penetrated by thewhitacre valve needle 234. The arms 258 and hooks 260 of the valve cover126 secure the two-piece adapter 288 within the valve cover 126.According to one embodiment, as shown in FIGS. 75 and 76, the septumholder 290 and the connector 292 have mating screw threads 296 and 298to secure one to the other.

FIG. 77 is a flow chart illustrating a process 310 of assembly of thedevice 100. In operation 312, the assembler obtains or manufacturers thespring components of the device 100, for example, the barrel spring 178and the needle actuation spring 200. Similarly, in operation 314, theassembler molds or obtains the injection molded components, for example,the main body 106, the needle actuation plunger 166, the outer telescopemember 146, and the retainer 270 or 280. Likewise, in operation 316, theassembler obtains or manufactures the primary container, for example,the syringe barrel 108. And in operation 318, the assembler obtains ormanufactures the remaining components of the flow pathway subassembly272, for example, the patient needle 124, the valve needle 234, thetubing 228, and the stopper 172.

Subsequently, in operation 320, the assembler assembles the power pack1380 using the spring components and the appropriate injection-moldedcomponents, for example, the needle actuation plunger 166, and thebarrel plunger 152. Additionally, the fluid path subassembly 264 or 278is assembled in operation 322. The remainder of the components, i.e.,those that are not in the power pack 1380 or the fluid path subassembly264 or 278, are assembled into the device body 1060.

The assembled fluid path subassembly 264 or 278 is packaged (operation326) and then sterilized (operation 328), thereby providing aself-contained, sterilized fluid path subassembly 264 or 278 that can beshipped to another location, for example, a pharmaceutical manufacturer,for aseptic filling (operation 330) with medicament. Subsequent to thefilling, the fluid path subassembly 264 or 278 is inspected for qualityduring high speed rotation about its central longitudinal axis, forexample, by a light-based inspection system, such as a laser inspectionsystem. One advantage of the inventive fluid path subassembly is that itcan be processed (i.e., packaged, sterilized, filled, and inspected)using equipment that is standardized for processing syringes, such as BDHypak™ syringes. Those fluid path subassemblies that pass inspection canthen be assembled into the device body 1060 along with the power pack1380 to complete the device (operation 334).

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from theprinciples and spirit of the invention. It is particularly noted thatthose skilled in the art can readily combine the various technicalaspects of the various elements of the various exemplary embodimentsthat have been described above in numerous other ways, all of which areconsidered to be within the scope of the invention, which is defined bythe appended claims and their equivalents.

1. A drug delivery device for injecting medicament, the devicecomprising: a main body having a surface for contacting a patient; anactuation button movably disposed relative to the main body; a reservoirdisposed within the main body for containing a medicament; at least oneneedle having: a distal end for insertion into a patient; and a lumenextending proximally from the distal end, wherein said lumen is fluidlyconnectable with the reservoir; a needle hub movably disposed within themain body to hold the at least one needle; and a removable needle coverselectively connectable to the needle hub to cover the distal end of theneedle, the needle cover including: a needle covering portion; and asafety extension extending internally through the main body from theneedle covering portion and adapted to engage the actuation button andprevent movement of the actuation button relative to the main body thatinitiates activation of the device.
 2. The device according to claim 1,wherein: the actuation button comprises a pair of cantilevered arms; andprior to needle cover removal, the safety extension extends between thecantilevered arms, preventing the cantilevered arms from moving towardeach other and disengaging from engaging structures in the main body,thereby preventing movement of the actuation button relative to the mainbody that initiates activation of the device.
 3. The device according toclaim 1, wherein subsequent to the expulsion of the medicament throughthe needle, the device automatically changes from an activated stage toan end-of dose stage.
 4. The device according to claim 3, whereinchanging from the activated stage to the end-of-dose stage retracts thedistal end of the needle within the main body.
 5. The device accordingto claim 1, wherein the needle is movably disposed with respect to themain body between a first position, in which the distal end is disposedwithin the main body, and a second position, in which the distal end isdisposed outside the main body.
 6. The device according to claim 5,wherein upon activation, the needle moves to the second position.
 7. Thedevice according to claim 1, further comprising an indicating mechanismto indicate when the device is currently in a pre-activated stage, anactivated stage, and an end-of dose stage.
 8. The device according toclaim 1, further comprising an indicating mechanism comprising: a needleactuation slider movably disposed within the main body and controllinginsertion and retraction of the needle through the movement thereof; anda stage indicating structure disposed on the needle actuation slider andhaving indicia denoting at least the activated stage and the end-of dosestage, the indicia being visible through a status viewport in the mainbody; wherein movement of the stage indicating structure corresponds tomovement of the needle actuation slider.
 9. The device according toclaim 8, wherein the stage indicating structure is fixedly secured tothe needle actuation slider.
 10. The device according to claim 9,wherein the stage indicating structure is integrally formed as a unitarystructure with the needle actuation slider.